Reading books, Listening devotional songs, Satsang activities
KUNAL J PATEL
Pharmaceutical
Vadodara
Summary
- Myself Kunal Patel, Pharmacy graduate from Rajiv Gandhi University of Health & Science, Bengaluru. I have 16.5 years of experience in aseptic production & quality with Experience of Green Field Project (Oncology plant) for start up of Sterile Formulation Facility and Brown field project.
- Have hands on experience of Aseptic processing, Troubleshooting & expertise in sterile manufacturing.
- Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency.
- Use independent decision-making skills and sound judgment to positively impact company success.
- Hardworking and passionate job seeker with strong organizational skills.
- Ready to help team achieve company goals.
- To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
- Qualified professional with proven ability to accurately and efficiently fill medication prescriptions while adhering to safety and quality control.
- Posse excellent communication skills, professional attitude and keen attention to detail. Dedicated to using latest technologies and processes to deliver highest level of efficiency.
- I am looking for an opportunity to perform for your organization & I believe my background will help me be an asset to your organization. I am very interested in becoming a part of an organization that is working together with life changing goal.
- My goal is to become associated with an organization where I can utilize my skills and gain further experience while enhancing the company’s productivity & reputation & continue my development in this profession.
Overview
17
17
years of professional experience
4
4
years of post-secondary education
1
1
Language
Work History
Manager
Sun Pharma
Halol
2023.02 - Current
- Provide technical inputs for trouble shooting, aseptic process and risk assessment
- Co-ordinate for cross functional team for operations and compliance for timely execution and analysis.
- Launched quality assurance practices for each phase of development
- Maximized performance by monitoring daily activities and mentoring team members.
- Improved safety procedures to create safe working conditions for workers.
- Ensure documentation meets GMP and regulatory guidelines
- Review Aseptic Process Validation protocols (media fill), BMR.
- Qualification of facilities, equipment and automation systems according to cGMP
- EU Annexure I Gap Assessment and implementation.
Sr. Manager
Mepro Pharmaceuticals Ltd
Jarod
2022.11 - 2023.01
- Handling operations & qualification on Fill finish line (Ampoule & Vial line)
- Evaluated hiring and promotions requests.
- Managed projects and introduced new systems, tools, and processes to achieve challenging objectives.
Manager
Alembic Pharmaceuticals Ltd
Panelav, Halol
2016.03 - 2022.11
- Handling operations on Fill finish line & Liposome manufacturing.
- Maximized performance by monitoring daily activities and mentoring team members.
- Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
- Established performance goals for employees and provided feedback on methods for reaching those milestones.
- Review of SOPs, BMR (Product & Media fill) & Qualification documents DQ/FS/DS/FDS/FAT/IQ/OQ/PQ/PPV/PRQ protocols.
Executive
Sun Pharma
Halol
2009.06 - 2016.03
- Implemented company policies, technical procedures and standards for preserving integrity and security of data, reports, and access.
- Introduced new methods, practices, and systems to reduce turnaround time.
- Identified trends and assessed opportunities to improve processes and execution.
- Interviewed, recruited and trained new onboarding candidates.
- Aseptic processing activities on vial and PFS line.
- Preparation of SOPs, BMR (Product & Media fill) & Qualification documents SAT/FAT/IQ/OQ/PQ/RQ protocols & its execution.
Production chemist
Elysium Pharmaceuticals Ltd
Dabhasa, Padra
2007.01 - 2009.05
- Batch manufacturing and filling activities.
- Adhered to safety policies, procedures and protocols for operational efficiency.
Education
Bachelor of Pharmacy - Pharmaceutical Sciences
SJM College of Pharmacy
Chitradurga, India 2003.01 - 2006.12
No Degree - High School
Jeevan Sadhna
Vadodara, India 2001.04 -
No Degree - School
EMS, Bhadran
Bhadran, India 2001.04 -
Skills
Commissioning, qualification and Media fill execution for Isolator line & skid. Expertise in Cycle development and cycle validation of VHP cycle (Hydrogen Peroxide) in Isolator, Aseptic processing.
Accomplishments
- FAT
- Training/Workshop
- Audits Faced: USFDA, MHRA, WHO, UNFPA, TGA & EU.
1. FAT of Thin Film Evaporator from SMS at Germany.
2. FAT of Suspension manufacturing tank from Adam Fabriwerk at Nashik, India.
3. FAT of Fill finish line with cRABS from NKP Pharma at Ahmedabad, India.
1. Training on Investigation handling and preparation by GxP consultants, USA.
2. Workshop on GAMP5, 21CFR Part 11, CSV, Data Integrity & Risk assessment at Alembic Pharmaceuticals Ltd.
3. Media fill workshop by PDA at New Delhi, India.
4. Training on Advanced validation system by Skytech systems
at Ahmedabad, India.
5. Training on Aseptic Filter Validation by Merck at Bengaluru, India.
Interests
Timeline
Manager
Sun Pharma
2023.02 - Current
Sr. Manager
Mepro Pharmaceuticals Ltd
2022.11 - 2023.01
Manager
Alembic Pharmaceuticals Ltd
2016.03 - 2022.11
Executive
Sun Pharma
2009.06 - 2016.03
Production chemist
Elysium Pharmaceuticals Ltd
2007.01 - 2009.05
Bachelor of Pharmacy - Pharmaceutical Sciences
SJM College of Pharmacy
2003.01 - 2006.12
No Degree - High School
Jeevan Sadhna
2001.04 -
No Degree - School
EMS, Bhadran
2001.04 -
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